Kornimate/medical-research-clean huggingface dataset:
the effect of percutaneous superior venae cava cannulation clamping on cerebral near infrared spectroscopy in mics

Conditions: Mitral Regurgitation

Summary: the use of minimally invasive cardiac surgery has progressed over the last 5-10 years to allow access to the heart through a small incision in the right chest. this avoids the use of a sternotomy incision through the bone in the front of the chest. the benefits of such an approach are cosmetic (smaller incision not easily visible) and faster recovery. the minimally invasive approach also eliminates the risk of sternal wound infection. minimally invasive cardiac surgery however poses additional challenges; one of the biggest is access to the large blood vessels which need to be cannulated to allow the heart lung machine to function. in conventional surgery, these vessels are easily accessed as they are entering or leaving the heart. in minimally invasive surgery, the cannula are placed into easily accessible arteries and veins, traditionally the femoral vessels. these vessels are smaller than those by the heart and so require smaller cannula, which provide challenges to the heart lung machine. one way around this is to use more cannulae and so cannulation of a vein in the neck is also performed. this cannula however, has been associated with neck hematoma, tearing of the vein and blood loss. while placement of the cannula in the neck is routine at lhsc now, when this surgery was first performed here 10 years ago, it was done so without the neck cannula and with no injury to patients. the purpose of this study therefore, is to more rigorously study the effect of the neck cannula on heart lung bypass, and more specifically to see if oxygen delivery to the organs, and the brain in particular is sufficient to avoid hypoxia.


Eligibility criteria:
inclusion criteria: * 18-80 years of age * elective mitral valve repair or replacement. * scheduled to have minimally invasive approach (right thoracotomy) * no contraindication to svc line placement exclusion criteria: * emergency surgery

Keywords: minimally invasive cardiac surgery cardiac surgery near infrared spectroscopy mitral valve repair mitral valve replacement
feasibility of a treatment free interval in newly diagnosed mm patients treated with daratumumab-lenalidomide-dexamethasone (hovon174mm)

Conditions: Multiple Myeloma

Summary: in the netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as dara-rd. in many patients this treatment results in suppressing the disease for a long time. the treatment is continued until it is not effective anymore and the disease progresses. but until now it is unknown whether continuous therapy also leads to prolonging life. in addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment. there are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. this may improve the quality of life.


Eligibility criteria:
inclusion criteria: * patient was diagnosed with mm, based on the imwg criteria, and measurable disease at the time of diagnosis (appendix a). * age ≥ 18 years. * patient was treated with 12 cycles (13 cycles is accepted) of dara-rd and will continue treatment with dara-rd. reduced dosing of lenalidomide, but not to less than 5 mg, and previous discontinuation or dose reduction of dexamethasone is allowed. * partial response or better after treatment with 12 cycles of dara-rd, without signs of biochemical progression. * anc ≥ 1.0x109/l and platelets ≥ 75x109/l. * patient is capable of giving informed consent. * written informed consent. exclusion criteria: * patient with non-secretory mm at diagnosis of the disease, i.e., before the start of treatment with dara-rd. * patient in whom a plasmacytoma was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with dara-rd. * patient in whom urine m-protein was the only measurable parameter at diagnosis of the disease, i.e., before the start of treatment with dara-rd. * patient in whom treatment with daratumumab, lenalidomide or both has been discontinued for whatever reason (patients may only have discontinued dexamethasone). * patient in whom continuation of treatment with dara-rd is deemed not feasible because of medical reasons. * any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
therapeutic termination of pregnancy and psychiatric implications

Conditions: Therapeutic Abortion With Complications; Personality Disorders; Trauma, Psychological; Reproductive Behavior; Post Traumatic Stress Disorder; Depression, Reactive

Summary: 25 parental couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before ttop and after one year from the procedure. women and unborn's fathers were also subjected to different psychometric questionnaires (ham-d, ham-a, bdi-ii, pcl-5, ipds, ctq, cd-risc-10).

the therapeutic interruption of pregnancy (ttop) may have psychiatric outcomes like depression, anxiety and post-traumatic stress disorder (ptsd). personality issues, childhood traumas and paternal consequences are too little investigated in current literature. the investigator's aim is exploring the contribution of maternal personality disorders and maternal history of childhood traumas to psychiatric outcomes after a ttop, paternal psychiatric outcomes and their role on their partner's psychopathological and psychiatric outcomes. 25 couples, with a prenatal diagnosis of fetal abnormality, had psychiatric evaluation for eligibility before ttop and after one year from the procedure. women and unborn's fathers were also subjected to different psychometric questionnaires (ham-d, ham-a, bdi-ii, pcl-5, ipds, ctq, cd-risc-10). at the time of first contact (t0) only women were subjected to a psychiatric clinical examination in order to evaluate their legal eligibility to ttop, according to italian law n. 194/78. at t0 women were also subjected to hamilton's rating scale for depression (hrsd or ham-d), hamilton's rating scale for anxiety (hrsa or ham-a), beck depression inventory (bdi-ii). at the follow up after 1 year from the first examination (t1) the parental couples were subjected to a questionnaire with multiple psychometric tests for mother and her partner. the female version included post-traumatic stress disorder checklist (pcl-5), iowa personality disorder screen (ipds), beck depression inventory (bdi-ii), connor-davidson resilience scale 10 (cd-risc 10) and short-form questionnaire on childhood trauma (ctq-sf). the male version included post-traumatic stress disorder checklist (pcl-5), iowa personality disorder screen (ipds), connor-davidson resilience scale 10 (cd-risc 10) and short-form questionnaire on childhood trauma (ctq-sf).

Eligibility criteria:
inclusion criteria: * pregnancy * prenatal diagnosis of fetal abnormality * adequate comprehension * legal eligibility to ttop procedure after psychiatric clinical evaluation * acceptance on a voluntary basis exclusion criteria: * incapacity * acute psychosis

Keywords: therapeutic abortion personality disorders childhood trauma post traumatic stress disorder depression
an exploratory study of nbi-34060 capsules and next day functioning

Conditions: Insomnia

Summary: nbi-34060 is an investigational (research) medication being studied in people with insomnia. the current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with nbi-34060. the study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.


Eligibility criteria:
inclusion criteria: * insomnia (dsm-iv diagnosed; at least one month) * nocturnal awakenings * usual bedtimes between 9:00pm and midnight. * bedtimes that do not vary by more than 2 hours on 5 or more nights per week. * a usual time in bed of 7 to 9 hours. exclusion criteria: * no serious concomitant illness * no other condition that could interfere with sleep
systemic bioavailability study of col-118 administered topically as a 0.18 % facial gel and brimonidine ophthalmic solution 0.2%

Conditions: Erythematous Rosacea

Summary: phase ii systemic bioavailability crossover study to measure the exposure of col-118 topical 0.18 % facial gel and brimonidine ophthalmic solution 0.2%

a double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (pk/pd) study of 0.18% col-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea. twenty male and female subjects with moderate to severe erythematous rosacea will be randomized into 2 groups of 10 subjects. each group will be randomized to receive 2 treatments (treatments a and b, in sequence 1: a/b or sequence 2: b/a), as follows: treatment a: one 1-g application of 0.18% col-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of advanced eye relief™ in each eye, once in the morning. 1 g of 0.18% col-118 facial gel is reapplied once after four hours; treatment b: one 1-g application of col-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. four hours after the first application 1-g of col-118 facial gel vehicle (0.0 mg brimonidine) is administered topically. there will be at least a 1-day washout between dose administrations (period 1 and period 2). blood samples for pk analysis of brimonidine levels will be collected at the following time points during period 1 and period 2: 0 hour (prior to dose) and at 1, 2, 3, 4 (prior to 2nd dose), 5, 6, 7, and 8 hours post-dose.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age * clinical diagnosis of rosacea * a score of ≥ 3 on the ceas * a score of ≥ 3 on the psa * iop ≥ 10 mm hg * non-pregnant and non-lactating females exclusion criteria: * history of hypersensitivity or allergies to any ingredient of the study drugs, unless approved by the investigator * use of brimonidine prescription medications within 14 days prior to check-in * use of any over-the-counter (otc), non-prescription preparations (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to check-in, unless deemed acceptable by the investigator * use of systemic or topical steroids applied to the face 14 days prior to check in * the use of any rx or otc products for the treatment of acne or rosacea within 14 days prior to check in * the use of isotretinoin within 180 days prior to check in

Keywords: erythematous rosacea facial gel brimonidine ophthalmic solution
sirolimus use in angioplasty for vascular access extension

Conditions: End Stage Renal Disease; Venous Stenosis

Summary: dialysis patients presenting for angioplasty intervention for graft failure will be randomized to receive either sirolimus or not receive sirolimus (standard of care) to assess the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure.

this is a randomized control study to determine the feasibility of using sirolimus peri-angioplasty to compare the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure to a control group who would not have received sirolimus

Eligibility criteria:
inclusion 1. hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an avf or avg 2. \> 18 years of age. 3. total white blood cell count \> 3 x 109 /l and platelet count \> 100.0 x 103/ul 4. fasting triglycerides \< 4.0 mmol/l, fasting cholesterol \< 7.8 mmol/l while on optimal lipid lowering therapy. exclusion criteria: 1. a woman who is pregnant or breastfeeding 2. active malignancy 3. concomitant treatment with immunosuppressant medications 4. active infection or treated for infection within the last 30 days 5. pre-existing interstitial lung disease 6. thrombocytopenia with platelets less than 100 109/l 7. previous renal or other solid organ transplant 8. preexisting liver failure 9. life expectancy less than 6 months 10. planned major surgery or major surgery within the last 6 months 11. history of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin). 12. known history of any coronary intervention within the 6 months prior to current screening 13. prior or current use of sirolimus or any of its derivatives within 3 months prior to angioplasty 14. active gastrointestinal disorder that may interfere with drug absorption 15. known to be hiv positive or known active hepatitis b or c infection 16. treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with sirolimus) that is not discontinued before starting sirolimus treatment.

Keywords: hemodialysis stenosis angioplasty sirolimus
comparison of the efficacy of dry needling, ischemic compression, and cross taping on masseter myofascial pain

Conditions: Temporomandibular Joint Disorders; Myofascial Pain

Summary: the goal of this clinical trial is to learn whether dry needling, ischemic compression, and cross tapes work to treat myofascial pain in masseter muscles in adults. it will also learn about the safety of this treatment. the main questions it aims to answer are: * do dry needling, ischemic compression, and cross tapes relieve masseter muscle pain? * which of these treatments provides the best relief from masseter muscle pain? researchers will compare these three treatments to see which is best for treating masseter muscle pain. participants will: treated with dry needling or ischemic compression or cross tapes only once visit the clinic one week, three months, and six months after treatment.

the taut band represents the most commonly observed muscular disorder, where myofascial trigger points may arise, causing referred pain in another location. therapeutic strategies applied for its treatment include dry needling, ischemic compression, and cross-taping. objectives: to compare the effectiveness of these treatment methods in reducing or alleviating the intensity of pain in the masseter. in this multicenter randomized clinical trial, the study sample underwent a clinical examination according to the diagnostic criteria for temporomandibular disorders to diagnose the presence of orofacial myofascial pain with taut bands in the masseter. participants were randomly allocated to three groups based on the treatment methods.

Eligibility criteria:
inclusion criteria: * patients with myofascial pain diagnosed according diagnostic criteria for temporomandibular disorders (dc-tmd). exclusion criteria: * pregnant women * other tmd-spectrum pathologies * anticoagulated and antiaggregated individuals * diabetes * blood disorders * fibromyalgia * autoimmune diseases in acute stages * neurological diseases * malignant tumor pathologies * patients with aichthyophobia * concomitant medication (opioids, antidepressants, myorelaxants)
infant formula in infants and children with cow's milk allergy

Conditions: Cow's Milk Allergy

Summary: this is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed ige-mediated cow's milk allergy (cma), followed by a 7-day open feeding of the experimental formula.


Eligibility criteria:
inclusion criteria: * participant's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment: 1. physician diagnosis of ige-mediated cma, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) and, detectable serum milk-specific ige \>0.7 kuᴀ/l or positive skin prick test wheal ≥5 mm; 2. documentation of milk-specific serum ige \>15 kuᴀ/l or \> 5 kuᴀ/l if younger than 1 year; 3. documented cow's milk skin prick test wheal \>10mm; 4. physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms. * participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges. * participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment. * parent(s) confirm their intention not to administer any products containing cow's milk protein during the study. * participant is between 3 months and 12 years of age at enrollment. * participant's parent(s) has voluntarily signed and dated an informed consent form (icf), approved by an independent ethics committee/institutional review board (iec/irb) and provided health insurance portability and accountability act (hipaa) (or other applicable privacy regulation) authorization prior to any participation in the study. exclusion criteria: * participant is partially or exclusively breastfed at the time of enrollment. * participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula. * significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases, or abnormalities other than cma, immunodeficiencies, unstable asthma, eczema and/or food allergies treated with biologics (omalizumab or other monoclonal antibody), fpies, eosinophilic esophagitis, and severe uncontrolled eczema. * previous severe anaphylactic reaction to cow's milk within the last two years., * an adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test. * participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent. * participant is consuming baked milk products. * use of and/or changing dose of high potency steroids.
association between ehg and risk of preterm delivery in women hospitalized for threatened premature delivery

Conditions: Preterm Birth

Summary: preterm delivery accounts for about 10% of deliveries in france. prematurity is the leading cause of perinatal morbidity and mortality in economically developed countries. despite the development of therapeutics and paraclinic examinations, this rate of preterm delivery remains stable or even increases. the use of medically assisted procreation techniques alone can not explain this rate. the analysis of the electrical activity of the uterus (electrohysterograms) is a promising technique for early diagnosis of the risk of premature delivery, allowing better management of the patients. this study is part of a european theme to study risk factors for the prevention of prematurity.


Eligibility criteria:
inclusion criteria: * patients arriving at maternity emergency for threat of premature birth between 26 sa and 35 sa defined by uterine contractions and a cervical modification * patient affiliated to a social security scheme exclusion criteria: * patient minor, * associated obstetric pathology: pre-eclampsia, premature rupture of membranes (rpm) * patient under tutelage or curatorship or deprived of public law
effect of albumin administration in hypoalbuminemic hospitalized patients with community-acquired pneumonia.

Conditions: Community-acquired Pneumonia; Hypoalbuminemia

Summary: community-acquired pneumonia (cap) remains a leading cause of death world-wide. hypoalbuminemia is associated with worse outcomes. however, whether albumin administration would have a beneficial effect in outcome in patients with cap remains uncertain. this project proposes to test the hypothesis of whether the administration of albumin in hypoalbuminemic patients with cap would increase the proportion of clinical stable patients at day 5.

this project will consist of a superiority, non-blinded, multicentre, randomized, phase 3, interventional controlled clinical trial. the estimated sample size is of 360 patients, who will be recruited from three spanish hospitals. hypoalbuminemic (≤30g/l) adult patients with cap will be randomly assigned (1:1) to receive standard care plus albumin (20g in 100ml) every 12 hours for 4 days or standard care alone. the primary endpoint will be the proportion of clinical stable patients at day 5, defined as stable vital signs for at least 24h, analyzed by intention to treat. the secondary endpoints will be time to clinical stability; duration of intravenous and total antibiotic treatment; length of hospital stay; intensive care unit admission; duration of mechanical ventilation and vasopressor treatment; adverse events; readmission within 30 days and all-cause mortality.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * diagnosis of cap (chest radiography consistent with cap and the presence of ≥2 following prespecified clinical criteria: fever or hypothermia; cough; purulent sputum; high white blood cell count; dyspnea; pleuritic chest pain; signs consistent with pneumonia on chest auscultation) * serum albumin concentration ≤ 30 g/l at presentation exclusion criteria: * pregnancy or lactation * immunosuppression (e.g. chemotherapy or radiotherapy within 90 days, immunosuppressive drugs, corticosteroids at a minimum dose of 15mg/day of prednisone within 2 weeks of enrolment, hiv with a cd4 count below 200, solid organ transplant recipients, hematopoietic cell transplant recipients). * severe clinical status with expected survival of less than 24h. * congestive heart failure (new york heart association classes 3 or 4) * any contraindication for albumin administration such as hypersensitivity to albumin. * clinical conditions in which there is another indication for albumin administration (e.g. hepatic cirrhosis with ascites, malabsorption syndrome and nephrotic syndrome). * absence or impossibility of obtaining informed consent from the patient/next of kin. * patient already included in another clinical trial testing a treatment method.

Keywords: community-acquired pneumonia albumin inflammation